MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 INTERMITTENT CATHETER; MAGIC 3 INTERMITTENT CATHETER

Model Number	53616
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the 9 units of intermittent catheter had bubble with relief.There was no patient impact.
Additional Manufacturer Narrative
The reported event is confirmed - manufacturing related.Visual evaluation noted 9 unopened intermittent catheters were received.Samples were tested.Visual evaluation of the samples noted bubbles in the catheter material of 3 of 3 samples tested that did not meet specifications.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure is mechanical failure.The product was not used for patient diagnosis or treatment.The product was influenced by the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the 9 units of intermittent catheter had bubble with relief.There was no patient impact.
Event or Problem Description
It was reported that the 9 units of intermittent catheter had bubble with relief.There was no patient impact.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related.Visual evaluation noted 1 photo sample of unopened intermittent catheters were received.Visual evaluation of the photo sample noted bubbles in the catheter material that did not meet specifications.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure is mechanical failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.

• Brand Name: MAGIC3 INTERMITTENT CATHETER
• Common Device Name: MAGIC 3 INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12086413
• Report Number: 1018233-2021-03899
• Device Sequence Number: 3870844
• Product Code: KOD
• UDI-Device Identifier: 00801741068584
• UDI-Public: (01)00801741068584
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2025
• Device Model Number: 53616
• Device Catalogue Number: 53616
• Device Lot Number: JUEY0985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/20/2021; 09/10/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/11/2021; 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other